Sector Specific Regulations
Rules and guidance issued by U.S. agencies governing how AI is built and used in specific health domains.
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| Issuing Body | Regulation Name | Sector | Date Issued/Significantly Updated | Policy Type | Status | Link to Text |
|---|---|---|---|---|---|---|
| Food and Drug Administration | Medical Devices | 2026-01-29 | Final Rule | Final | LINK | |
| World Health Organization (WHO) | Guidance | 2026-01-14 | Final Guidance | Final | LINK | |
| European Medicines Agency U.S. Food and Drug Administration | Drugs & Biologics | 2026-01-14 | Final Guidance | Final | LINK | |
| New Mexico Counseling and Therapy Practice Board | Cross-cutting Healthcare | 2025-11-18 | Final Rule | In Effect | LINK | |
| Food and Drug Administration | Cross-cutting Healthcare | 2025-09-24 | Final Guidance | Final | LINK | |
| Joint Commission; Coalition for Health AI | Hospitals | 2025-09-17 | Guidance | Active | LINK | |
| Food and Drug Administration | Cross-cutting Healthcare | 2025-09-12 | Notice | Issued | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2025-09-12 | Guidance | Active | LINK | |
| Federal Trade Commission | Cross-cutting AI policy | 2025-09-11 | Study | In Development | LINK | |
| National Institute of Standards and Technology | Cross-cutting AI policy | 2025-09-10 | Standards Pilot | Comments Open | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting AI policy | 2025-08-26 | Guidance | Active | LINK | |
| National Institutes of Health | Biomedical Research | 2025-08-05 | Notice | Issued | LINK | |
| Centers for Medicare & Medicaid Services | Hospitals | 2025-08-04 | Final Rule | Final | LINK | |
| Agency for Healthcare Research and Quality | Patient Safety | 2025-07-01 | Final Rule | Issued | LINK | |
| Centers for Medicare & Medicaid Services – Innovation Center (CMMI) | Medicaid/Medicare | 2025-07-01 | Model Notice | Active | LINK | |
| Centers for Medicare & Medicaid Services | Insurance | 2025-04-15 | Final Rule | Final | LINK | |
| Department of Health and Human Services | Cross-cutting Healthcare | 2025-01-10 | Guidance | In Effect | LINK | |
| Food and Drug Administration | Medical Devices | 2025-01-07 | Draft Guidance | Draft | LINK | |
| Food and Drug Administration | Drugs & Biologics | 2025-01-07 | Draft Guidance | Draft | LINK | |
| Department of Health and Human Services | Health IT | 2024-12-17 | Final Rule | Final | LINK | |
| Assistant Secretary for Technology Policy | Health IT | 2024-12-17 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Hospitals | 2024-08-28 | Final Rule | Final | LINK | |
| Food and Drug Administration | Medical Devices | 2024-08-22 | Draft Guidance | Draft | LINK | |
| Federal Trade Commission | Health IT | 2024-05-30 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2024-05-06 | Final Rule | Final | LINK | |
| U.S. Department of Health & Human Services (HHS) | Cross-cutting Healthcare | 2024-04-29 | Action Plan | Active | LINK | |
| Department of Health and Human Services | Privacy & Security | 2024-04-26 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Insurance | 2024-04-23 | Final Rule | Final | LINK | |
| Department of Health and Human Services | Cross-cutting Healthcare | 2024-03-18 | Guidance | Issued | LINK | |
| Food and Drug Administration | Medical Devices | 2024-03-01 | Final Guidance | Final | LINK | |
| Food and Drug Administration | Cross-cutting Healthcare | 2024-02-22 | Notice | Final | LINK | |
| Department of Health and Human Services | Cross-cutting Healthcare | 2024-02-16 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Health IT | 2024-02-08 | Final Rule | Final | LINK | |
| Department of Health and Human Services | Cross-cutting Healthcare | 2024-02-08 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services (CMS) | Medicaid/Medicare | 2024-02-06 | FAQ | In Effect | LINK | |
| Food and Drug Administration | Medical Devices | 2024-02-02 | Final Rule | Final | LINK | |
| Assistant Secretary for Technology Policy | Health IT | 2024-01-09 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2023-11-22 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2023-11-22 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting AI policy | 2023-11-16 | Final Rule | Final | LINK | |
| National Institutes of Health | Research | 2023-06-23 | Policy Notice | Issued | LINK | |
| Food and Drug Administration | Cross-cutting AI policy | 2023-05-10 | Discussion Paper | In Development | LINK | |
| Food and Drug Administration | Medical Devices | 2023-01-03 | Docket | Draft | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2022-11-23 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting AI policy | 2022-11-18 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2021-11-19 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2021-11-16 | Final Rule | Final | LINK | |
| U.S. FDA; Health Canada; UK MHRA | Medical Devices | 2021-10-27 | Final Guidance | Final | LINK | |
| U.S. Department of Health & Human Services | Cross-cutting Healthcare | 2021-09-30 | Final Guidance | Final | LINK | |
| Centers for Medicare & Medicaid Services | Hospitals | 2021-08-13 | Final Rule | Final | LINK | |
| Food and Drug Administration | Cross-cutting AI policy | 2021-01-12 | Program/Framework | Final | LINK | |
| Food and Drug Administration | Medical Devices | 2021-01-12 | Action Plan | Issued | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2020-12-29 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting AI policy | 2020-12-28 | Final Rule | Final | LINK | |
| Department of Health and Human Services | Cross-cutting Healthcare | 2020-12-02 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2018-11-23 | Final Rule | Final | LINK | |
| Centers for Medicare & Medicaid Services | Cross-cutting Healthcare | 2016-11-15 | Final Rule | Final | LINK | |
| Arizona Board of Behavioral Health Examiners | Behavioral Health | 2025-11-02 | Final Rule | In Effect | LINK | |
| Food and Drug Administration | Diagnostics / Laboratory Developed Tests | 2025-09-19 | Final Rule | Vacated / Historical | LINK |